Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Jul 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a new drug called HRS-8427 affects the way the body processes two other medicines, bupropion and midazolam, in healthy adults. These two medicines are broken down in the liver by special enzymes, and the researchers want to see if HRS-8427 changes how these enzymes work. Understanding this helps doctors know if it’s safe to use HRS-8427 with other medications.

The study is looking for healthy men and women between 18 and 45 years old who meet certain health and weight requirements. Participants should not have allergies to the study drugs or serious health issues like heart, liver, or lung problems. Women cannot be pregnant or breastfeeding, and both men and women must agree to use birth control during the study. If you join, you’ll be closely monitored by the research team, and you’ll receive the study drugs in a controlled setting to see how your body handles them. This trial is not yet recruiting participants, but if you fit the criteria, it could be an important way to help improve medication safety in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy subjects aged 18 to 45 years old (including 18 and 45 years old, based on the time of signing the informed consent form), both male and female.
• • 2. The weight of female subjects was ≥45 kg, the weight of male subjects was ≥50 kg, and the body mass index (BMI) was within the range of 19.0-26.0 kg/m2
• • 3. The female subjects were not in the pregnancy or lactation period, and the pregnancy examination results before the test were negative; Male or female subjects agreed to take the investigator-approved effective contraceptive measures during the trial as required by the investigator.
• • 4. Before the trial, a thorough understanding of the nature, significance, potential benefits, possible inconveniences and potential risks of the trial was obtained. The participant voluntarily participated in this clinical trial, was able to communicate well with the researcher, comply with the requirements of the entire study, and signed a written informed consent form.
• Exclusion Criteria:
• • 1. Those with a history of allergies to food, drugs, etc., especially those known to be allergic to β -lactam antibacterial drugs and midazolam, bupropion, or those with an allergic constitution.
• • 2. Have had or are currently suffering from diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, musculoskeletal system and nervous system, etc.
• • 3. Conforming to the contraindications of midazolam use or not suitable for midazolam use .
• • 4. Comply with the contraindications for bupropion use or are not suitable for bupropion use .
• • 5. The 12-lead electrocardiogram was abnormal and was judged by the researcher as unsuitable to participate in this study .
• • 6. Laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), physical examination, vital signs (ears, blood pressure, pulse, respiration), and chest X-ray results, etc., which are judged by clinicians as abnormal and of clinical significance .
• • 7. Those with positive infectious disease tests (human immunodeficiency virus antibody, hepatitis B surface antigen, anti-hepatitis C virus antibody, anti-Treponema pallidum specific antibody).
• • 8. Those who have undergone major surgical operations within the three months prior to screening; Or those who have undergone surgery that may affect the in vivo process or safety evaluation of the studied drug; Or those who plan to undergo surgical operations during the research period.
• • 9. Those who have participated in drug clinical trials as subjects and taken the investigational drug within 3 months prior to screening, or who plan to participate in other clinical trials during this study period .
• • 10. Those who have used any inducers or inhibitors of CYP2B6 and CYP3A enzymes within one month before taking the study drug for the first time.